By Anna Lynn Spitzer
Irvine, Ca, August 15th, 2013 -- Some of it is intuitive, other aspects are more complex, but knowledge of research regulations and compliance is essential to anyone entering a lab or conducting an experiment. This year’s seven SURF-IT students are a lot more familiar with the topic after this week’s lunchtime seminar delivered by SURF-IT co-chairs Stuart Ross and Said Shokair.
“The goal here is not to have you memorize every rule,” Ross told the Fellows, who were gathered around a large conference table. “We want to treat this as ‘Compliance 101.’ We want you to know enough to ask questions and make sure you’ll not blunder into something because you didn’t know it was a possible issue.”
Ross shared information about UC Irvine’s Office of Research Administration, which includes units devoted to sponsored projects, research protections and conflict of interest in research. “Just know that while you’re at UCI this is where you go to get answers about compliance topics,” he said.
Compliance hinges upon specifics. “The first answer when someone asks about compliance,” Ross said, should be “it depends.”
Conflict of interest, for example. Ross said avoiding all conflict of interest is impossible but it’s essential to be aware of potential conflict and savvy enough to manage the situation to reduce problems. Considerations include size of impact and degree of connection to or involvement in the conflict.
Conflict of interest affects scientific integrity. Ross urged the Fellows to avoid even the appearance of impropriety. Does one own stock in a company he is evaluating a drug for? Does she have a share in a startup company that is funding her professor’s research? Do researchers conduct outside consulting for a grant sponsor? “You’ve got to ask yourself: How’s this going to look on the front page of the Orange County Register? Does it pass the smell test? If not, at that point, back off and find some other way,” he advised.
Conflicts can also result in misuse of public property, unbalanced allocation of time and effort, improper channeling of research funds, and failure to preserve the university’s intellectual property and related financial interests.
Complete disclosure is essential. Ross shared two types of disclosure forms with the students: one from the National Science Foundation and the other from the State of California. The NSF and other federal agencies, like the National Institutes of Health, are concerned with maintaining objectivity in research, Ross explained, while California is more interested in preventing misuse of public property and distortion of public decisions.
In all cases, disclosure forms must be completed and submitted, even if there is nothing to disclose. A “positive” disclosure requires greater detail, and a review committee will recommend a solution to potential conflict, or in the most severe cases, shut down the project.
Penalties, while rare, are serious. Projects can be completely suspended and investigators can be debarred. “Your career can be over for several years,” Ross warned.
The solution is simple. Keep interests separate. Know the limits and categories that apply to your circumstances. Ask questions, always disclose everything, and include third parties in important decisions.
Animal research was another topic of discussion. Highlights included the need to: justify the number of animals used; review possible alternatives to live animals (computer models, for example); keep pain and suffering to a minimum; and most importantly, justify the project as being necessary for training, as a pilot study or as systematic research.
Ross gave the students a handy way to remember these criteria: “the three Rs – reduction, refinement and replacement.”
He also stressed the importance of adequate facilities and personnel, including hygiene, emergency preparedness, and food and housing for the animals.
Ross is familiar with IACUCs – Institutional Animal Care and Use Committees – after serving on one for 14 years. He said they must include a veterinarian, a research scientist, a community member and a non-scientist. These committees are required by law to consider the scientific merit of each project, and have the final say as to whether each proceeds.
Finally, students were told of key agencies, organizations and documents that can help them decipher additional animal research issues and protocols.
Said Shokair took a different approach to his presentation. He emphasized RCR – Responsible Conduct of Research – before sharing several scenarios with the students and asking them to answer questions about each.
“We’re going to play with your mind a little bit,” he told the Fellows. “Ethics is a much wider area than you might think … and you’re expected to make the right decisions.”
Each hypothetical research scenario was followed by a discussion of its moral and ethical dilemmas. Topics included exclusion of data points, project sponsorship, managing bias, misrepresenting publication, mentor-student expectations and responsibilities, and research authorship.
Shokair stressed rules and consequences. “We don’t want to scare you but ... you’re talking about your reputation and the reputation of the university.”
He recommended that the students read “On Being a Scientist,” a National Academies guide to responsible research conduct. He also urged them to speak up about wrongdoing. “If you’re not comfortable with how a graduate student is doing things, go to the mentor. If you’re unhappy with your mentor’s behavior, go to the department chair.” He mentioned the Whistleblower Protection Act as well, emphasizing the confidentiality of a whistleblower’s identity.
Shokair summed up his presentation by telling the students that responsible research conduct is a universal concept. “These rules all apply everywhere, no matter where you do your research,” he said. “I don’t care if you’re doing research on the moon; you need to be sensitized to these issues.”